UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

[X]QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended June 30, 2017March 31, 2018

 

OR

[  ]TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from _______ to

 

Commission file number:001-37769

 

VBI VACCINES INC.

(Exact name of registrant as specified in its charter)

 

British Columbia, Canada N/A
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)

 

222 Third Street, Suite 2241

Cambridge, Massachusetts

 02142
(Address of principal executive offices) (Zip Code)

 

Registrant’s telephone number, including area code:617-830-3031

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes [X] No [  ]

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 229.405232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes [X] No [  ]

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer”, and “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer [  ]Accelerated filer [  ][X]
  
Non-accelerated filer [  ] (Do not check if a smaller reporting company)Smaller reporting company [X][  ]
  
 Emerging growth company [X]

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [X]

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes [  ] No [X]

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

 

Common Shares, no par value per share40,229,37164,215,727
(Class)Outstanding at July 31, 2017April 25, 2018

 

 

 

 

 

 

VBI VACCINES INC.

FORM 10-Q FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2017MARCH 31, 2018

 

TABLE OF CONTENTS

 

  Page
PART I - FINANCIAL INFORMATION5
   
Item 1.Condensed Consolidated Financial Statements5
   
 Condensed Consolidated Balance Sheets - June 30, 2017March 31, 2018 (unaudited) and December 31, 201620175
   
 Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30,March 31, 2018 and 2017 and 2016 (unaudited)6
   
 Condensed Consolidated StatementStatements of Stockholders’ Equity (unaudited)7
   
 Condensed Consolidated Statements of Cash Flows for the sixthree months ended June 30,March 31, 2018 and 2017 and 2016 (unaudited)8
   
 Notes to Condensed Consolidated Financial Statements (unaudited)9
   
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations20
   
Item 3.Quantitative and Qualitative Disclosures About Market Risk2827
  
Item 4.Controls and Procedures2827
   
PART II - OTHER INFORMATION2928
   
Item 1.Legal Proceedings2928
   
Item 1A.Risk Factors2928
   
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds2928
   
Item 3.Defaults Upon Senior Securities2928
   
Item 4.Mine Safety Disclosure2928
   
Item 5.Other Information2928
   
Item 6.Exhibits2928
   
Signatures30

 2

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND OTHER INFORMATION
CONTAINED IN THIS REPORT

 

This quarterly report on Form 10-Q (this “Form 10-Q”) contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements give our current expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts. You can find many (but not all) of these statements by looking for words such as “approximates,” “believes,” “hopes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “plans,” “would,” “should,” “could,” “will”, “may,” or other similar expressions in this Form 10-Q. In particular, these include statements relating to future actions; prospective products, applications, customers and technologies; future performance or results of anticipated products; anticipated expenses; and projected financial results. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from our historical experience and our present expectations or projections described under the sections in this Quarterly Report on Form 10-Q entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and in the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 20162017 annual report on the Form 10-K filed with the Securities and Exchange Commission on March 20, 2017.February 26, 2018. Factors that could cause actual results to differ from those discussed in the forward-looking statements include, but are not limited to:

 

the timing of, and our ability to, obtain and maintain regulatory approvals for our clinical trials, products and product candidates;
  
the timing and results of our ongoing and planned clinical trials for products and product candidates;
  
the amount of funds we require for our immuno-oncology and infectious disease vaccine candidate pipeline;
  
the potential benefits of strategic partnership agreements and our ability to enter into strategic partnership arrangements;
  
our ability to effectively execute and deliver our plans related to commercialization, marketing and manufacturing capabilities and strategy;
  
ourability to license our intellectual property;
  
our ability to maintain a good relationship with our employees;
  
the suitability and adequacy of our office, manufacturing and research facilities and our ability to secure term extensions or expansions of leased space;
  

our ability to manufacture, or to have manufactured, any products we develop to the standards and requirements of regulatory agencies;

  

the ability of our vendors to manufacture and deliver materials that meet regulatory agency and our standards and requirements in order to meet planned timelines and milestones;

  3
any disruption in the operations of our manufacturing facility where we manufacture all of our clinical and commercial supplies of Sci-B-Vac™;
 

our compliance with all laws, rules and regulations applicable to our business and products;
  
our ability to continue as a going concern;
  
our history of losses;
  
our ability to generate revenues and achieve profitability;
  
emerging competition and rapidly advancing technology in our industry that may outpace our technology;
  
customer demand for our products and product candidates;
  
the impact of competitive or alternative products, technologies and pricing;
  
general economic conditions and events and the impact they may have on us and our potential customers;
  
our ability to obtain adequate financing in the future on reasonable terms, as and when we need it;
  
our ability to implement network systems and controls that are effective at preventing cyber-attacks, malware intrusions, malicious viruses and ransomware threats;
  
our ability to secure and maintain protection over our intellectual property;
  
changes to legal and regulatory processes for biosimilar approval and marketing could reduce the duration of market exclusivity for our products;
 
our ability to maintain our existing licenses for intellectual property; and
  
our success at managing the risks involved in the foregoing items.items; and
other factors discussed in this Form 10-Q.

Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for us to predict all risk factors and uncertainties. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

 

Unless otherwise stated or the context otherwise requires, the terms “VBI,” “we,” “us,” “our” and the “Company” refer to VBI Vaccines Inc. and its subsidiaries.

 

Unless indicated otherwise, all references to the U.S. Dollar, Dollar or $ are to the United States Dollar, the legal currency of the United States of America and all references to € mean Euros, the legal currency of the European Union. We may also refer to NIS, which is the New Israeli Shekel, the legal currency of Israel, and the Canadian Dollar or CAD, which is the legal currency of Canada.

 

Except for per share amounts or as otherwise specified to be in millions, amounts presented are stated in thousands.

 4

PART I—FINANCIAL INFORMATION

Item 1.Condensed Consolidated Financial Statements

Item 1. Condensed Consolidated Financial Statements

 

VBI Vaccines Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

(in thousands, except number of shares)share amounts)

 

 June 30, 2017  December 31, 2016  March 31, 2018  December 31, 2017 
 (Unaudited)    (unaudited)   
CURRENT ASSETS             
Cash $15,642  $32,282  $58,094  $67,694 
Accounts receivable, net 226  10   167   143 
Inventory, net 895  830   783   788 
Prepaid expenses  371   951 
Other current assets  2,081   1,236   937   850 
Total current assets 18,844  34,358   60,352   70,426 
             
NON-CURRENT ASSETS              
Long-term deposits 173  167 
Other long term assets 520  487 
Other long-term assets  1,196   675 
Property and equipment, net 2,254  1,850   2,942   2,245 
Intangible assets, net 61,532  59,507   61,600   63,336 
Goodwill  8,672   8,385   8,731   8,974 
Total non-current assets  73,151   70,396   74,469   75,230 
             
TOTAL ASSETS $91,995  $104,754  $134,821  $145,656 
             
CURRENT LIABILITIES              
Accounts payable $2,353  $2,018  $2,537  $1,810 
Other current liabilities 6,660  5,562   11,202   9,826 
Deferred revenues  -  34   74   - 
Current portion of long-term debt  400  - 
Current portion of long-term debt – related party  2,200   1,600 
Total current liabilities 9,413  7,614   16,013   13,236 
             
NON-CURRENT LIABILITIES              
Long-term debt, net of debt discount of $2,758 and $3,344, respectively and current portion 12,142  11,956 
Long-term deferred tax liability -  428 
Long-term debt, net of debt discount – related party  11,236   11,538 
Liabilities for severance pay 408  356   442   426 
Deferred revenues, net of current portion  669   669   669   669 
Total non-current liabilities 13,219  13,409   12,347   12,633 
             
COMMITMENTS AND CONTINGENCIES (NOTE 10) - - 
COMMITMENTS AND CONTINGENCIES (NOTE 11)        
             
STOCKHOLDERS’ EQUITY             
Common shares (unlimited authorized; no par value) (40,229,371 and 40,018,495 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively) 134,040  133,312 
Common shares (unlimited authorized; no par value) (2018 issued – 64,215,727 2017 - issued 64,078,781)  201,899   201,806 
Additional paid-in capital 59,134  58,595   61,625   60,891 
Accumulated other comprehensive loss (1,180) (3,196)
Accumulated other comprehensive (loss) income  (837)  1,065 
Accumulated deficit  (122,631)  (104,980)  (156,226)  (143,975)
Total stockholders’ equity  69,363   83,731   106,461   119,787 
             
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $91,995  $104,754  $134,821  $145,656 

 

See accompanying Notes to Condensed Consolidated Financial Statements

 5

VBI Vaccines Inc. and Subsidiaries

 

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

(in thousands, except per share data)

  Three months ended June 30  Six months ended June 30 
  2017  2016  2017  2016 
             
Revenues $344  $82  $471  $130 
                 
Operating expenses:                
Cost of revenue  1,357   703   2,632   1,080 
Research and development  4,528   2,123   9,182   2,377 
General and administration  2,771   3,138   5,816   5,118 
Total operating expenses  8,656   5,964   17,630   8,575 
                 
Loss from operations  (8,312)  (5,882)  (17,159)  (8,445)
                 
Interest expense, net  (743)  (3)  (1,447)  28 
Foreign exchange gain (loss)  42   (531)  524   978 
Loss before incomes taxes  (9,013)  (6,416)  (18,082)  (7,495)
                 
Income tax benefit  -   -   431   - 
                 
NET LOSS $(9,013) $(6,416)  (17,651)  (7,495)
                 
Net loss per share of common shares, basic and diluted $(0.22) $(0.23) $(0.44) $(0.32)
                 
Weighted-average number of common shares outstanding, basic and diluted  40,089,193   27,618,730   40,057,906   23,266,920 
                 
Other comprehensive income (loss):                
Foreign currency translation adjustments  1,890   381   2,016   (310)
                 
COMPREHENSIVE LOSS $(7,123) $(6,035) $(15,635) $(7,805)

See accompanying Notes to Condensed Consolidated Financial Statements

 6

VBI Vaccines Inc. and Subsidiaries

Condensed Consolidated Statement of Stockholders’ Equity

(Unaudited)

(in thousands, except number of shares)

  Number of Common Shares  Share Capital  Additional Paid-in Capital  Accumulated Other Comprehensive Loss - Foreign Currency Translation Adjustments  Accumulated Deficit  Total
Stockholders’ Equity
 
                   
BALANCE AS OF DECEMBER 31, 2016  40,018,495  $133,312  $58,595  $(3,196) $(104,980) $83,731 
                         
Stock-based compensation  179,499   627   539   -   -   1,166 
Common shares issued for services  25,000   85   -   -   -   85 
Common shares issued on exercise of stock options  6,377   16   -   -   -   16 
Net loss                  (17,651)  (17,651)
Foreign currency translation adjustments  -   -   -   2,016   -   2,016 
                         
BALANCE AS OF JUNE 30, 2017  40,229,371  $134,040  $59,134  $(1,180) $(122,631) $69,363 

See accompanying Notes to Condensed Consolidated Financial Statements

 7

VBI Vaccines Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(in thousands)

  For the Six Months Ended
June 30
 
  2017  2016 
       
CASH FLOWS FROM:        
         
CASH FLOWS FROM OPERATING ACTIVITIES        
Net loss $(17,651) $(7,495)
Adjustments to reconcile net loss to cash used in operating activities:        
Depreciation and amortization  353   280 
Deferred taxes  (431)   - 
Stock-based compensation  1,251   1,042 
Amortization of debt discount  586   - 
         
Net change in operating working capital items, net of business acquisitions:        
(Increase) decrease in accounts receivable  (212)  80 
(Increase) decrease in inventory  17   (149)
(Increase) decrease in other current assets  (796)  166 
(Decrease) increase in other long-term assets  24   (197)
(Decrease) increase in accounts payable  49   (3,004)
(Decrease) increase in deferred revenues, including related parties  (99)  2,390 
Increase in other current liabilities  777   - 
Net cash flows used in operating activities  (16,132)  (6,887)
         
INVESTING ACTIVITIES        
Cash acquired in business combination  -   2,126 
Changes in long-term deposits  -   (27)
Purchase of property and equipment  (422)  (232)
Net cash flows provided by/(used in) investing activities  (422)  1,867 
         
FINANCING ACTIVITIES        
Proceeds from issuance of common shares for cash      13,610 
Proceeds from exercise of stock options  16   - 
Repayment of long-term debt  -   (150) 
Net cash flows provided by financing activities  16   13,460 
         
Effect of exchange rates on cash  (102)  892 
         
CHANGE IN CASH FOR THE PERIOD  (16,640)  9,332 
         
CASH, BEGINNING OF PERIOD  32,282   12,476 
         
CASH, END OF PERIOD $15,642  $21,808 
         
Supplementary disclosure of cash flow information:        
Cash paid during the period for interest $906  $- 
Non-cash investing and financing activities:        
Issuance of common stock on acquisition of VBI DE -  63,534 
Warrants issued in acquisition  -   940 
Options issued in acquisition  -   3,020 
Capital expenditures included in other current liabilities  143   4 

See accompanying Notes to Condensed Consolidated Financial Statements

 8

VBI Vaccines Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(Unaudited)

(in thousands, except share and per share amounts)

 

1.NATURE OF BUSINESS AND CONTINUATION OF BUSINESS
  For the Three Months Ended
March 31
 
  2018  2017 
       
Revenues $178  $127 
         
Operating expenses:        
Cost of revenue  1,413   1,275 
Research and development  6,964   4,654 
General and administration  3,425   3,045 
Total operating expenses  11,802   8,974 
         
Loss from operations  (11,624)  (8,847)
         
Interest expense, net of interest income of $202 and $12 (including related party – see Note 8)  (539)  (704)
Foreign exchange (loss) gain  (88)  482 
Loss before incomes taxes  (12,251)  (9,069)
         
Income tax benefit  -   431 
         
NET LOSS $(12,251) $(8,638)
         
Net loss per share of common shares, basic and diluted $(0.19) $(0.22)
         
Weighted-average number of common shares outstanding, basic and diluted  64,179,605   40,026,270 
         
Other comprehensive (loss) income - currency translation adjustments  (1,902)  126 
         
COMPREHENSIVE LOSS $(14,153) $(8,512)

See accompanying Notes to Condensed Consolidated Financial Statements

VBI Vaccines Inc. and Subsidiaries

Condensed Consolidated Statements of Stockholders’ Equity

(Unaudited)

(in thousands, except share amounts)

  Number of Common Shares  Share Capital  Additional Paid-in Capital  Accumulated Other Comprehensive Income (Loss) - Currency Translation Adjustments  Accumulated Deficit  Total Stockholders’ Equity 
                   
BALANCE AS OF DECEMBER 31, 2017  64,078,781  $201,806  $60,891  $1,065  $(143,975) $119,787 
                         
Stock-based compensation  135,000   88   734           822 
Common shares issued on exercise of stock options  1,946   5               5 
Net loss                  (12,251)  (12,251)
Currency translation adjustments              (1,902)      (1,902)
                         
BALANCE AS OF MARCH 31, 2018  64,215,727  $201,899  $61,625  $(837) $(156,226) $106,461 

See accompanying Notes to Condensed Consolidated Financial Statements

VBI Vaccines Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(in thousands)

  For the Three Months Ended
March 31
 
  2018  2017 
       

CASH FLOWS FROM OPERATING ACTIVITIES

        
Net loss $(12,251) $(8,638)
Adjustments to reconcile net loss to cash used in operating activities:      - 
Depreciation and amortization  149   171 
Stock-based compensation  822   624 
Amortization of debt discount  299   288 
Deferred taxes  -   (431)
Net change in operating working capital items:        
(Increase) in accounts receivable  (27)  (32)
(Increase) in inventory  (1)  (78)
Decrease in prepaid expenses  54   67 
(Increase) in other current assets  (106)  (95)

(Increase) in other long-term assets

  (19)  (27)
(Decrease) increase in accounts payable  614   (609)
(Decrease) increase in deferred revenues  84   (73)
Increase in other current liabilities  1,804   589 
Net cash flows used in operating activities  (8,578)  (8,244)
         
INVESTING ACTIVITIES        
Purchase of property and equipment  (1,015)  (266)
Net cash flows provided by investing activities  (1,015)  (266)
         
FINANCING ACTIVITIES        
Proceeds from issuance of common shares for cash, upon exercise of stock options  5   16 
Net cash flows provided by financing activities  5   16 
         
Effect of exchange rates on cash  (12)  (279)
         
CHANGE IN CASH FOR THE PERIOD  (9,600)  (8,773)
         
CASH, BEGINNING OF PERIOD  67,694   32,282 
         
CASH, END OF PERIOD $58,094  $23,509 
         
Supplementary information:        
Interest paid – related party $474  $450 
Capital expenditures included in other current liabilities  -   76 

See accompanying Notes to Condensed Consolidated Financial Statements

VBI Vaccines Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(Unaudited)

(in thousands, except per share amounts)

1. NATURE OF BUSINESS AND CONTINUATION OF BUSINESS

 

Corporate Overview

 

VBI Vaccines Inc. (formerly SciVac Therapeutics, Inc.(the “Company” or “VBI”) was incorporated under the laws of British Columbia, Canada on April 9, 19651965.

The Company and has the followingits wholly-owned subsidiaries:subsidiaries, VBI Vaccines (Delaware) Inc., a Delaware corporation (“VBI DE”); VBI DE’s wholly-owned subsidiary, Variation Biotechnologies (US), Inc., a Delaware corporation (“VBI US”); Variation Biotechnologies Inc. a Canadian company (“VBI Cda”) and the wholly-owned subsidiary of VBI US;US (“VBI Cda”); and SciVac Ltd. an Israeli company (“SciVac”); and SciVac USA, LLC. a Florida limited liability company (“SciVac US”) and the wholly owned subsidiary of SciVac. VBI Vaccines Inc. and its subsidiaries are collectively referred to as the “Company,” “we,” “us,”“Company”, “we”, “us”, “our” or “VBI”.

 

The Company’s registered office is located at Suite 1700, Park Place, 666 Burrard Street, Vancouver, BC V6C 2X8 with its principal office is located at 222 Third Street, Suite 2241, Cambridge, MassachusettsMA 02142. In addition, the Company has manufacturing facilities located in Rehovot, Israel and research facilities located in Ottawa, Ontario, Canada.

 

The Company operates in one segment and therefore segment information is not presented.

Principal Operations

 

We areVBI is a commercial stagecommercial-stage, biopharmaceutical company developing next generation vaccines to address unmet needs in infectious disease and immuno-oncology. VBI’s first marketedWe currently manufacture our product, is Sci-B-Vac®, a hepatitisthird generation Hepatitis B (“HBV”) vaccine that mimics all three viral surface antigens of the hepatitis B virus. Sci-B-Vacfor adults, children and newborns, which is approved for use in Israel and 14 other countries. Sci-B-Vac has not yet been approved by the U.S. Food and Drug Administration (the “FDA”), the European Medicines Agency (the “EMA”) or Health Canada. VBI is currently conducting a global Phase III clinical program to obtain FDA, EMA and Health Canada market approvals for commercial sale of Sci-B-Vac in the United States, the European Union (the “EU”), and Canada, respectively. Our wholly-owned subsidiary SciVac Ltd., manufactures Sci-B-Vac in Rehovot, Israel.Israel, currently manufactures and sells Sci-B-Vac.

 

Following our merger with VBI DE on May 6, 2016 (the “VBI-SciVac Merger”), weWe are also developing technologies that seek to enhance vaccine protection in large, underserved markets. These include an enveloped “Virus Like Particle” or “eVLP” vaccine platform that allows for the design of enveloped virus-like particle vaccines that closely mimic the target viruses. VBI is advancing our two platform technologies – our Enveloped Virus-Like Particlea pipeline of eVLP vaccines, with lead programs in human cytomegalovirus (“eVLP”CMV”) platform technology, an infection that, while common, can lead to serious complications in babies and our Lipid Particle Vaccinepeople with weak immune systems, and is involved in the progression of glioblastoma multiforme (“LPV”GBM”) technology.

-Our eVLP platform technology enables the development of enveloped virus-like particle vaccines that closely mimic the target virus to elicit a potent immune response. We are advancing a pipeline of eVLP vaccines, with lead programs in both infectious disease, with our congenital cytomegalovirus (“CMV”) vaccine, and in immuno-oncology, with our therapeutic glioblastoma multiforme (“GBM” or “glioblastoma”) vaccine candidate.

 9

-Our LPV thermostability technology is a proprietary formulation of lipids and process that allows vaccines and biologics to preserve stability, potency, and safety at temperatures outside of the most common cold chain storage requirements of 2oC to 8oC.

, which is a form of brain cancer.

Liquidity and Going Concern

 

The Company has a limited operating history and faces a number of risks, including but not limited to, uncertainties regarding the success of the development and commercialization of its development activities,products, demand and market acceptance of the Company’s products and reliance on major customers. The Company anticipates that it will continue to incur significant operating costs and losses in connection with the development of its products.

 

The Company has an accumulated deficit of $122,631$156,226 as of June 30, 2017,March 31, 2018 and cash outflows from operating activities of $(16,132)$8,578 for the sixthree months ended June 30, 2017.March 31, 2018.

 

The Company will require significant additional funds to conduct clinical and non-clinical studies,trials, achieve regulatory approvals, and, subject to such approvals, commercially launch its products. The Company plans to finance future operations with existing cash reserves. Additional financing, if required, could be a combination of existing cash reserves, proceeds from the issuance of equity securities, the issuance of additional debt, andor revenues from potential collaborations, if any. There is no assurance the Company will manage to obtain these sources of financing.financing, if required. The above conditions raise substantial doubt about the Company’s ability to continue as a going concern. The report of our independent registered public accounting firm on our consolidated financial statements for the year ended December 31, 2016 contains an explanatory paragraph regarding our ability to continue as a going concern. The condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result should the Company be unable to continue as a going concern.

 

On May 15, 2017, the Company entered into an equity distribution agreement (the “Distribution Agreement”) with a registered broker-dealer, as sales agent (the “Sales Agent”), pursuant to which the Company may offer and sell, from time to time, through the Sales Agent its common shares having an aggregate offering price of up to $30 million. The Company is not obligated to sell any common shares under the Distribution Agreement. Subject to the terms and conditions of the Distribution Agreement, the Sales Agent will use commercially reasonable efforts consistent with its normal trading and sales practices, applicable state and federal law, rules and regulations, and the rules of the NASDAQ Capital Market to sell shares from time to time based upon the Company’s instructions, including any price, time or size limits specified by the Company. The Company will pay the Sales Agent a commission of 3.0% of the aggregate gross proceeds from each sale of common shares occurring pursuant to the Distribution Agreement, if any. The Distribution Agreement may be terminated by the Sales Agent or the Company at any time upon ten days’ notice to the other party, or by the Sales Agent at any time in certain circumstances.2. SIGNIFICANT ACCOUNTING POLICIES

2.SIGNIFICANT ACCOUNTING POLICIES

 

Basis of Presentation and Consolidation

 

The Company’s fiscal year ends on December 31 of each calendar year. The accompanying unaudited condensed consolidated financial statements have been prepared in U.S. dollars (“USD”) and pursuant to the rules and regulations of the United States Securities and Exchange Commission (“SEC”), the instructions to Form 10-Q and the provisions of Regulation S-X pertaining to financial statements.for interim reporting. Accordingly, certain information and footnote disclosures normally included in the financial statements prepared in accordance with United States of America generally accepted accounting principles (“U.S. GAAP”), have been condensed or omitted pursuant to such rules and regulations. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from these estimates and are not necessarily indicative of the results to be expected for any future period or the entire fiscal year. The December 31, 20162017 consolidated balance sheet in this document was derived from the audited consolidated financial statements and does not include all of the disclosures required by U.S. GAAP. The condensed consolidated financial statements and notes included in this quarterly report on Form 10-Q (this “Form 10-Q”) should be read in conjunction with the financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 20162017 (the “2016“2017 10-K”), as filed with the SEC on March 20, 2017.February 26, 2018.

 10

 

The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries: SciVac, SciVac USA, and from May 6, 2016 the accounts of VBI DE, VBI US and VBI Cda. Intercompany balances and transactions between the Company and its subsidiaries are eliminated in the condensed consolidated financial statements.

 

In the opinion of management, these condensed consolidated financial statements include all adjustments and accruals of a normal and recurring nature necessary to fairly state the results of the periods presented. The results for the periods presented are not necessarily indicative of results to be expected for the full year or for any future periods.

Reclassification

Certain prior year amounts have been reclassified to conform with the current quarter presentation and were not material to our condensed consolidated financial statements.

 

Significant Accounting Policies

 

The significant accounting policies used in the preparation of these condensed consolidated financial statements are disclosed in the 20162017 10-K, and there have been no changes to the Company’s significant accounting policies during the sixthree months ended June 30, 2017.March 31, 2018, other than revenue recognition discussed below.

Revenue recognition

Revenues consist primarily of product sales of vaccines and research services. We apply the five-step model outlined in Accounting Standards Codification Topic 606, Revenue from Contracts from Customers (ASC 606). Revenue is recognized when control of the promised products or services is transferred to the Company’s customers, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those products or services (the transaction price). We adopted ASC 606 effective January 1, 2018. As a result, we have changed our accounting for revenue recognition. We applied ASC 606 using the modified retrospective method and there was no material impact to our consolidated financial statements related to the adoption of ASC 606.

 

Foreign currency

 

The functional and reporting currency of the Company is the USD. Each of the Company’s subsidiaries determines its own respective functional currency, and this currency is used to separately measure each entity’s financial position and operating results.

 

Assets and liabilities of foreign operations with a different functional currency from that of the Company are translated at the closing rate at the end of each reporting period. Profit or loss items are translated at average exchange rates for all the relevant periods. All resulting translation differences are recognized as a component of accumulated other comprehensive loss.loss (income).

 

Foreign exchange gains and losses arising from transactions denominated in a currency other than the functional currency of the entity involved, are included in the condensed consolidated statements of operations.

 

Use of Estimates

 

Preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual amounts could differ from the estimates made. We continually evaluate estimates used in the preparation of the condensed consolidated financial statements for reasonableness. Appropriate adjustments, if any, to the estimates used are made prospectively based upon such periodic evaluation. The significant areas of estimation include determining the deferred tax valuation allowance, the estimated lives of property and equipment and intangible assets,estimating accrued clinical expenses, the inputs in determining the fair value of equity basedthe in-process research and development (“IPR&D”) and goodwill as part of the annual impairment analysis, the inputs in determining the fair value of equity-based awards and warrants issued as well as the values ascribed to assets acquired and liabilities assumed in a business combination.combinations. Actual results may differ from those estimates.estimates made.

 

Goodwill and In-Process Research and Development

 

The Company’s intangiblesintangible assets determined to have indefinite useful lives including in-process research and development (“IPR&D”)&D and goodwill, are tested for impairment annually, or more frequently if events or circumstances indicate that the assets might be impaired.

 11

Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired in a business combination. Goodwill can become impaired in certain Such circumstances includingcould include but are not limited to: (1) a significant adverse change in legal factors or in business climate, (2) unanticipated competition, or (3) an adverse action or assessment by a regulator.

Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired in a business combination. When evaluating goodwill for impairment, we may first perform an assessment qualitatively whether it is more likely than not that a reporting unit’s carrying amount exceeds its fair value, referred to as a “step zero” approach. The Company intends to adopt ASU 2017-04, “Intangibles – Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment” which has eliminated Step 2 from the goodwill impairment test as part of its annual impairment test. Under Step 2, an entity had to perform procedures to determine the fair value at the impairment testing date of its assets and liabilities following the procedure that would be required in determining the fair value of assets acquired and liabilities assumed in a business combination. Under the amendments in this update,Subsequently (if necessary after step zero), an entity should perform its goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. Under Accounting Standards Update (“ASU”) 2017-04, “Intangibles – Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment”, Step 2 from the goodwill impairment test has been eliminated and goodwill impairment is measured as the excess of the carrying amount of the reporting unit over its fair value. The Company has established August 31st as the date for its annual impairment test of goodwill.

 

The goodwill is in VBI Cda and the change in carrying value from December 31, 2017 relates to currency translation adjustments which decreased goodwill by $243 for the three-month period ended March 31, 2018.

The costs of rights to IPR&D projects acquired in an asset acquisition are expensed in the consolidated statements of operations unless the project has an alternative future use. These costs include initial payments incurred prior to regulatory approval in connection with research and development agreements that provide rights to develop, manufacture, market and/or sell pharmaceutical products.

 

IPR&D acquired in a business combination is capitalized as an intangible asset and tested for impairment at least annually until commercialization, after which time the IPR&D is amortized over its estimated useful life. The impairment test compares the carrying amount of the IPR&D asset to its fair value. If the carrying amount exceeds the fair value of the asset, such excess is recorded as an impairment loss.

 

Fair value measurements of financial instruments

 

Accounting guidance defines fair value as the price that would be received to sell an asset or paid to transfer a liability (the exit price) in an orderly transaction between market participants at the measurement date. The accounting guidance outlines a valuation framework and creates a fair value hierarchy in order to increase the consistency and comparability of fair value measurements and the related disclosures. In determining fair value, the Company uses quoted prices and observable inputs. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from independent sources.

 

The fair value hierarchy is broken down into three levels based on the source of inputs as follows:

 

Level 1 — Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities.

 

Level 2 — Valuations based on observable inputs and quoted prices in active markets for similar assets and liabilities.

 

Level 3 — Valuations based on inputs that are unobservable and models that are significant to the overall fair value measurement.

 

Financial instruments recognized in the condensed consolidated balance sheet consist of cash, accounts receivable, and other current assets, accounts payable and other current liabilities. The Company believes that the carrying value of the aforementionedits current financial instruments approximates their fair values due to the short-term nature of these instruments. The Company does not hold any derivative financial instruments.

 

The carrying amounts of the Company’s deposits and other long-term assets approximate their respective fair values.

 

At June 30, 2017March 31, 2018 and December 31, 2016,2017, the fair value of the Company’sour outstanding debt, which is considered level 3 in the fair value hierarchy, is estimated to be approximately $15,472$15,306 and $15,012,$15,157, respectively.

3. NEW ACCOUNTING PRONOUNCEMENTS

 12

In determining the fair value of the long-term debt as of June 30, 2017 and December 31, 2016 the Company used the following assumptions:

  June 30, 2017  December 31, 2016 
Long-term debt:        
Interest rate  12.2%  12.0%
Discount rate  11.5%  13.5%
Expected time to payment in months  29   35 

3.NEW ACCOUNTING PRONOUNCEMENTS

 

Recently Adopted Accounting Pronouncements

Stock Compensation

In March 2016, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (the “ASU”) No. 2016-09, “Compensation - Stock Compensation (Topic 718),” which simplifies several aspects of the accounting for share-based payment award transactions, including the income tax consequences, classification of awards as either equity or liabilities, classification on the statement of cash flows and accounting for forfeitures. ASU No. 2016-09 is effective for fiscal years beginning after December 15, 2016, including periods within those fiscal years. Our adoption of this ASU in the first quarter of 2017 did not have a material impact on our condensed consolidated financial statements.

Cash Flow Classification

The FASB issued ASU 2016-15, an accounting standard that affects the classification of certain cash receipts and cash payments on the statement of cash flows. The standard provides guidance on eight issues: debt prepayment or extinguishment costs, settlement of zero-coupon bonds or bonds issued at a discount with insignificant cash coupon, contingent consideration payments made after a business combination, proceeds from the settlement of insurance claims, proceeds from the settlement of corporate-owned life insurance policies, distributions received from equity method investees, beneficial interests in securitization transactions, separately identifiable cash flows and applying the predominance principle. The standard is effective for public business entities for fiscal years beginning after December 15, 2017 including periods within those fiscal years.

The FASB issued ASU 2016-18, an accounting standard that requires companies to include cash and cash equivalents that have restrictions on withdrawal or use in total cash and cash equivalents on the statement of cash flows. The standard does not define restricted cash or restricted cash equivalents, but companies will need to disclose the nature of the restrictions. The standard is effective for public business entities for fiscal years beginning after December 15, 2017 including interim periods within those fiscal years.

Our adoption of these ASUs in the first quarter of 2017 did not have an impact on our condensed consolidated financial statements.

Recently Issued Accounting Standards, not yet Adopted

 

Revenue from Contracts with Customers

 

In May 2014, the FASBFinancial Accounting Standards Board (the “FASB”) issued Accounting Standards Update No. 2014-09,Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”). ASU 2014-09 outlines a single comprehensive model to use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance, including industry-specific guidance. ASU 2014-09 also requires entities to disclose sufficient information, both quantitative and qualitative, to enable users of financial statements to understand the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. An entity should apply the amendments in this ASU using one of the following two methods: (1) retrospectively to each prior reporting period presented with a possibility to elect certain practical expedients, or, (2) on a modified retrospective basis with the cumulative effect of initially applying ASU 2014-09 recognized at the date of initial application. If an entity elects the latter transition method, it also should provide certain additional disclosures. For a public entity, the ASU as amended is effective for annual periods beginning after December 15, 2017, including interim reporting periods within that reporting period. Given the Company’s current level of revenue, we do not expect a significant impact from theOur adoption of this new accounting guidance on our financial statements and footnote disclosures.

 13

Leases

In February 2016 the FASB issued ASU 2016-02: Leases. The ASU introduces a lessee model that results in most leases impacting the balance sheet by requiring reporting entities to recognize lease assets and lease liabilities for substantially all lease arrangements. The new standard also aligns many of the underlying principles of the new lessor model with those in ASC 606, the FASB’s new revenue recognition standard (e.g., those related to evaluating when profit can be recognized). Furthermore, the ASU addresses other concerns related to the current leases model. For example, the ASU eliminates the requirement in current U.S. GAAP for an entity to use bright-line tests in determining lease classification. The update is effective, for fiscal years beginning after December 15,January 1, 2018, including interim periods within those fiscal years. The Company is currently evaluating the impact this new guidance will have on its financial statements and related disclosures.

Accounting for Income Taxes on Intercompany Transfers

The FASB recently issued ASU 2016-16, an accounting standard that requires the seller and buyer to recognize at the transaction date the current and deferred income tax consequences of intercompany asset transfers. The FASB expects the new standard to cause volatility in companies’ effective tax rates, particularly for those that transfer intangible assets to subsidiaries. The standard is effective for public business entities for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. While the Company continues to assess the potential impact of this standard, the adoption of this standard isdid not expected to have a material impact on our condensed consolidated financial statements.statements and footnote disclosures.

 

Recognition and Measurement of Financial Assets and Financial Liabilities

 

In January 2016, the FASB issued ASU 2016-01, “Financial Instruments – Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities”. This update will change the income statement impact of equity investments held by an entity; disclosures related to fair value of financial instruments and presentation of financial assets and liabilities. ASU 2016-01 is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. Entities must apply the standard using a cumulative-effect adjustment to the balance sheet as of the beginning of the fiscal year of adoption. Except for certain early application guidance, early adoption is not permitted. The Company is currently assessingWe adopted this ASU effective January 1, 2018 and are no longer required to disclose the impact that adopting this new ASU will have on our financial statements andfair value assumptions in determining the fair value of the long-term debt in the footnote disclosures.

 

Clarifying the Scope of Asset Derecognition Guidance andRecently Issued Accounting for Partial Sales of Nonfinancial AssetsStandards, not yet Adopted

Leases

In February 2017, The2016 the FASB issued ASU 2017-05, “Other Income – Gains2016-02: Leases. The ASU introduces a lessee model that results in most leases impacting the balance sheet. The ASU addresses other concerns related to the current leases model. Under ASU 2016-02, lessees will be required to recognize for all leases with terms longer than 12 months, at the commencement date of the lease, a lease liability, which is a lessee’s obligation to make lease payments arising from a lease measured on a discounted basis, and Losses froma right-to-use asset, which is an asset that represents the Derecognition of Nonfinancial Assets (Subtopic 610-12): Clarifyinglessee’s right to use or control the Scope of Assets Derecognition Guidance and Accounting for Partial Sales of Nonfinancial Assets”. This amendment in this update clarifies the guidance on accounting for derecognitionuse of a nonfinancialspecified asset and an in-substance nonfinancial asset and applies only whenfor the asset (or asset group) does not meetlease term. Leases will be classified as either finance or operating, with classification affecting the definitionpattern of a business; defines in-substance nonfinancial assets; and provides guidance for partial sales of nonfinancial assets. ASU 2017-05expense recognition. The update is effective for annual reporting periodsfiscal years beginning after December 15, 2017,2018, including interim periods within those fiscal years. While we continue to evaluate the Company continueseffect of adopting this guidance on our consolidated financial statements and related disclosures, we expect our operating leases, as disclosed in Note 11, will be subject to assess the potential impact of this standard, thenew standard. We will recognize right-of-use assets and operating lease liabilities on our consolidated balance sheets upon adoption, of this standard is not expected to have a material impact on its financial statements.which will increase our total assets and liabilities.

4.INTANGIBLES

  June 30, 2017 
  Gross Carrying
amount
  Accumulated
Amortization
  Cumulative Currency Translation  Net Book
Value
 
             
Patents $669  $(366) $31  $334 
IPR&D assets  61,500   -   (302)  61,198 
                 
  $62,169  $(366) $(271) $61,532 

 

13 14
 

 

4. INVENTORY, NET

 

  December 31, 2016 
  Gross Carrying
amount
  Accumulated
Amortization
  Cumulative Currency Translation  Net Book
Value
 
             
Patents $669  $(334) $(4) $331 
IPR&D assets  61,500   -   (2,324)  59,176 
                 
  $62,169  $(334) $(2,328) $59,507 

Inventory is stated at the lower of cost or market and consists of the following:

  March 31, 2018  December 31, 2017 
       
Finished goods $47  $99 
Work-in-process  381   119 
Raw materials  355   570 
  $783  $788 

5. INTANGIBLES

     March 31, 2018 
  Gross Carrying
Amount
  Accumulated
Amortization
  Cumulative Impairment Charge  Cumulative Currency Translation  Net Book
Value
 
Patents $669  $(414) $-  $30  $285 
IPR&D assets  61,500   -   (300)  115   61,315 
                     
  $62,169  $(414) $(300) $145  $61,600 

     December 31, 2017 
  Gross Carrying
Amount
  Accumulated
Amortization
  Cumulative Impairment Charge  Cumulative Currency Translation  Net Book
Value
 
Patents $669  $(397) $-  $33  $305 
IPR&D assets  61,500   -   (300)  1,831   63,031 
                     
  $62,169  $(397) $(300) $1,864  $63,336 

 

The Company amortizes intangible assets with finite lives on a straight-line basis over their estimated useful lives. The amortization expense for the three and six months ended June 30, 2017 was $15 and $30, respectively compared

Amortization related to the three and six months ended in 2016 of $16 and $31, respectively.

The IPR&D assets relate to the May 6, 2016 VBI-SciVac Merger and will not begin amortizing until the Company commercializes its products. Future costs incurred to extend the life

6. OTHER CURRENT LIABILITIES

Other current liabilities consisted of the patents will be expensed.following:

 

5.LOSS PER SHARE OF COMMON SHARES
  March 31, 2018  December 31, 2017 
Accrued expenses (including clinical trial accrued expenses) $10,033  $7,921 
Payroll and employee-related costs  1,056   1,699 
Other current liabilities  113   206 
         
  $11,202  $9,826 

7. LOSS PER SHARE OF COMMON SHARES

 

Basic loss per share is computed by dividing net loss applicable to common stockholders by the weighted average number of shares of common shares outstanding during each period. Diluted loss per share includes the effect, if any, from the potential exercise or conversion of securities, such as warrants, and stock options, which would result in the issuance of incremental shares of common shares unless such effect is anti-dilutive. In computing the basic and diluted net loss per share applicable to common stockholders, the weighted average number of shares remains the same for both calculations due to the fact that when a net loss exists, dilutive shares are not included in the calculation as their effect would be anti-dilutive. These potentially dilutive securities are more fully described in Note 8,9, Stockholders’ Equity and Additional Paid-in Capital.

 

The following potentially dilutive securities outstanding at June 30,March 31, 2018 and 2017 and 2016 have been excluded from the computation of diluted weighted average shares outstanding, as they would be antidilutive:

 

 As at June 30, 
 2017 2016  March 31, 2018  March 31, 2017 
          
Warrants 2,069 364   2,618,824   2,068,824 
Stock options and equity awards  2,960   2,757   3,960,549   3,120,525 
  5,029   3,121   6,579,373   5,189,349 

8. LONG-TERM DEBT – RELATED PARTY

6.LONG-TERM DEBT

 

As at June 30, 2017March 31, 2018 and the December 31, 2016,2017, the outstandinglong-term debt is as follows:

 

  

June 30, 2017

  December 31, 2016
      
Long-term debt, net of deferred financing costs and unamortized debt discount based on an imputed interest rate of 20.5% of $2,758 and $3,344 at June 30, 2017 and December 31, 2016, respectively $12,542  $11,956
        
Less: current portion  (400)  -
        
  $12,142  $11,956

 15

  March 31, 2018  December 31, 2017 
       
Long-term debt, net of debt discount $13,436  $13,138 
         
Less: current portion  2,200   1,600 
         
  $11,236  $11,538 

 

As a result of the VBI-SciVac Merger,On May 6, 2016, the Company through VBI DE assumed a term loan facility with Perceptive Credit Holdings, LP, a related party, (the “Lender”) in the amount of $6,000 (the “Facility”), with an initial advance of $3,000 drawn down on prior to the VBI-SciVac Merger. As of the date of the VBI-SciVac Merger, the Company assumed an amount of $2,361 in the Facility.. On December 6, 2016, the Company amended the Facility (the “Amended Facility”) and raised an additional $13,200 which was combined with the remaining balance from the Facility of $1,800. The total principal outstanding at June 30, 2017,March 31, 2018, including the $300 exit fee discussed below, is $15,300 before$15,300. Borrowings under the net deferred financing costs and unamortized debt discountAmended Facility are secured by all of $2,758.VBI assets. The principal on the Amended Facility accrues interest at an annual rate equal to the greater of (a) one-month LIBOR (subject to a 5.00% cap) or (b) 1.00%, plus the applicable margin.Applicable Margin. The applicable marginApplicable Margin will be 11.00%. The first eighteen months are interest only. The interest rate as of June 30, 2017March 31, 2018 was 12.2%12.88%. Upon the occurrence of an event of default, and during the continuance, of an event of default, the applicable marginApplicable Margin, defined above, will be increased by 4.00% per annum. The Amended FacilityThis term loan facility matures December 6, 2019 and includes both financial and non-financial covenants, including a minimum cash balance requirement of $2,500.requirement. The Company was in compliance with these covenants as of June 30, 2017.March 31, 2018. Pursuant to the Amended Facility, the Company agreed to appoint a representative of the Lender to the BoardPerceptive Credit on our board of directors (the “Board”) who is also a portfolio manager of the Company’s largest shareholder.shareholder, effective January 2018, Perceptive Credit’s representative resigned from our Board.

 

The Company’s obligations under the Amended Facility are secured on a senior basis by a lien on substantially all of the assets of the Company including the Company’s interest in its subsidiaries, and its U.S. and Canadian subsidiaries and guaranteed by the Company and its U.S. and Canadian subsidiaries. The Amended Facilityand Restated Credit Agreement also contains customary events of default.

In connection with the Amended Facility, on December 6, 2016, the Company issued to the Lender two tranches of warrants. The first tranche was a warrant to purchase 363,771 common shares at an exercise price of $4.13 per share and the second tranche was a warrant to purchase 1,341,282 common shares at an exercise price of $3.355 per share. The total proceeds from the Amended Facility attributed to the warrants was $2,793, based on the relative fair value of the warrants as compared to the sum of the fair values of the warrants and debt. This attribution resulted in the debt being issued at a discount. The Company incurred $360 of debt issuance costs and is required to pay an exit fee of $300 upon full repayment of the debt resulting in additional debt discount. The total debt discount of $3,453 is being charged to interest expense using the effective interest method over the term of the debt. As of June 30,March 31, 2018, and December 31, 2017, the unamortized debt discount is $2,758.$1,864 and $2,163. The Company recorded $586$299 and $288 of interest expense related to the amortization of the debt discount during the sixthree months ended June 30, 2017.March 31, 2018 and 2017, respectively.

Total related party interest expense, including the amortization of the debt discount, was $773 and $738 for the three months ended March 31, 2018 and 2017, respectively. Such amounts are included in Interest expense, net in the accompanying condensed consolidated statements of operations and comprehensive loss.

 

The following table summarizes the future principal payments that the Company expects to make for long-term debt:

 

 Period ending
June 30,
  Principal
payments on
Amended Facility
and exit fee
 
2017  $- 
2018   400 
2019   14,900 
   $15,300 
   Principal
payments on
Amended Facility
and exit fee
 
 Remaining 2018  $1,600 
 2019   13,700 
    $15,300 

9. STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL

7.DEFERRED REVENUE AND RELATED PARTY TRANSACTIONS

Prior to the VBI-SciVac Merger, one of the Company’s directors was also the chairman of the board of Kevelt AS (“Kevelt”), a wholly owned subsidiary of OAO Pharmsynthez (“Pharmsynthez”), a shareholder of the Company and was also the chairman of the board of Pharmsynthez. Following the VBI-SciVac Merger, in accordance with the merger agreement, this director resigned.

On April 26, 2013, SciVac entered into a Development and Manufacturing Agreement (“DMA”) with Kevelt, pursuant to which SciVac agreed to develop the manufacturing process for the production of clinical and commercial quantities of certain materials in drug substance form. On July 30, 2016, the Company received a letter of termination from Kevelt, in part containing a request for refund of $2.5 million it had previously transferred to the Company. Such amount is included in other current liabilities in the accompanying condensed consolidated financial statements.

 16

SciVac entered into a services agreement with OPKO Biologics Ltd. (“OPKO Bio”), a wholly-owned subsidiary of OPKO Health, Inc., a related party shareholder of the Company, dated as of March 15, 2015, as amended on January 25, 2016, pursuant to which SciVac agreed to provide certain aseptic process filling services to OPKO Bio. The terms of the services agreement are based on market rates and comparable to other non-related party service agreements.

See Note 6, Long-term Debt, for the Facility from a lender that is also affiliated with the Company’s largest shareholder.

   

Six months ended

June 30

 
   2017  2016 
Services revenues from related parties:         
OPKO Bio  $3  $7 

Subsequent to the VBI-SciVac Merger on May 6, 2016, Kevelt and Pharmsynthez are no longer considered related parties due to the common shareholder no longer having significant influence.

8.STOCKHOLDERS’ EQUITY AND ADDITIONAL PAID-IN CAPITAL

 

Stock option plans

 

The Company’s stock option plans are approved by and administered by the Company’s board of directors (the “Board”)Board and its Compensation Committee. The Board designates, in connection with recommendations from the Compensation Committee, eligible participants to be included under the plan, and designates the number of options, exercise price and vesting period of the new options.

 

2006 VBI US Stock Option Plan

 

No further options will be issued under the 2006 VBI US Stock Option Plan (the “2006 Plan”). As at June 30, 2017,March 31, 2018, there were 1,3111,140,053 options outstanding under the 2006 Plan.

 

2013 Stock Incentive Plan

 

No further options will be issued under the 2013 Equity Incentive Plan (the “2013 Plan”). As at June 30, 2017,March 31, 2018, there were 54,613 options outstanding under the 2013 Plan.

 

2014 Equity Incentive Plan

 

No further options will be issued under the 2014 Equity Incentive Plan (the “2014 Plan”). As at June 30, 2017,March 31, 2018, there were 735645,222 options outstanding under the 2014 Plan.

 

2016 VBI Equity Incentive Plan

 

The 2016 VBI Equity Incentive Plan (the “2016 Plan”) is a rolling incentive plan that sets the number of common shares issuable under the 2016 Plan, together with any other security-based compensation arrangement of the Company, at a maximum of 10% of the aggregate common shares issued and outstanding on a non-diluted basis at the time of any grant under the 2016 Plan. The 10% maximum is inclusive of options granted under all equity incentive plans. The 2016 Plan is an omnibus equity incentive plan pursuant to which the Company may grant equity and equity-linked awards to eligible participants in order to promote the success of the Company following the VBI-SciVac Merger by providing a means to offer incentives and to attract, motivate, retain and reward persons eligible to participate in the 2016 Plan. Grants under the 2016 Plan include a grant or right consisting of one or more options, stock appreciation rights (“SARs”), restricted share units (“RSUs”), performance share units (“PSUs”), shares of restricted stock or other such award as may be permitted under the 2016 Plan. As at June 30, 2017,March 31, 2018, there were 4111,639,114 options and 498531,547 stock awards outstanding under the 2016 Plan.

 17

 

The aggregate number of common shares remaining available for issuance for awards under this plan was 579total 1,936,496 at June 30, 2017.

March 31, 2018.

Activity related to stock options is as follows (in thousands, except for weighted average exercise price):follows:

 

  Number of Stock Options  

Weighted Average Exercise

Price

 
       
Balance outstanding at December 31, 2016  2,168  $4.45 
         
Granted  302  $3.60 
Exercised  (6) $2.50 
Forfeited  (2) $2.50 
         
Balance outstanding at June 30, 2017  2,462  $4.34 
         
Exercisable at June 30, 2017  1,534  $4.39 
         
Options expected to vest at June 30, 2017  928  $4.26 
  Number of Stock Options  Weighted Average Exercise Price 
       
Balance outstanding at December 31, 2017  2,351,395  $4.44 
         
Granted  1,265,000  $4.19 
Forfeited  (185,447)  4.00 
Exercised  (1,946) $2.50 
         
Balance outstanding at March 31, 2018  3,429,002  $4.35 
         
Exercisable at March 31, 2018  1,747,927  $4.50 

 

Information relating to restricted stock units is as follow (in thousands, except forfollow:

  Number of Stock Awards  Weighted Average Fair Value at Grant Date 
       
Unvested shares outstanding at December 31, 2017  424,379  $3.99 
         
Granted  150,000  $4.26 
Vested and exercised  (17,832) $4.94 
Forfeited  (25,000) $3.87 
         
Unvested shares outstanding at March 31, 2018  531,547  $4.03 

In determining the amount of stock-based compensation the Company used the Black-Scholes option pricing model to establish the fair value of options granted by applying the following weighted average fair value at grant date):assumptions:

 

  Number of Stock Awards  

Weighted

Average Fair

Value at Grant

Date

 
       
Unvested shares outstanding at December 31, 2016  639  $3.88 
         
Granted  57  $4.72 
Vested  (165) $3.94 
Forfeited  (33) $3.90 
         
Unvested shares outstanding at June 30, 2017  498  $3.95 
  2018  2017 
       
Volatility  114.53%  87.22%
Risk free interest rate  2.48%  2.31%
Expected term in years  5.77   6.3 
Expected dividend yield  0%  0%
Weighted average fair value per option $3.53  $3.12 

 

The fair value of the options expected to vest will beis recognized as an expense on a straight-line basis over the vesting period.period and forfeitures are accounted for when they occur. The total stock-based compensation expense recorded in the three and six months ended June 30,March 31, 2018 and 2017 and 2016 was as follows:

  Three months ended June 30  Six months ended June 30 
  2017  2016  2017  2016 
             
Research and development $202  $760  $387  $760 
General and administrative  408   282   831   282 
Cost of revenues  17   -   33   - 
Total stock based compensation $627  $1,042  $1,251  $1,042 

 

 18
  

Three months ended

March 31

 
  2018  2017 
       
Research and development $191  $185 
General and administrative  618   423 
Cost of revenues  13   16 
Total stock-based compensation expense $822  $624 

 

 

9.INCOME TAXES

10. INCOME TAXES

 

The Company operates in U.S., Israel and Canadian tax jurisdictions. Its income is subject to varying rates of tax, and losses incurred in one jurisdiction cannot be used to offset income taxes payable in another.

 

The Company determines its annual effective tax rate at the end of each interim period based on the year to date period results. Since the Company is incorporated in Canada, it is required to use Canada’s statutory tax rate of 26.00% in the determination of the estimated annual effective tax rate.

The Company’s effective tax rate on loss before tax for the three and six months ended June 30, 2017March 31, 2018 of 0% and 2.38%, respectively (0%(4.78% - 2016)2017) differs from the Canadian statutory rate of 26%26.00% primarily due to the recognition ofrecording a valuation allowance on the Canadian deferred tax assets as well as onin excess of the otherremaining Canadian deferred tax liability and the effect of recording a valuation allowance against deferred tax assets in all other jurisdictions.

 

The Company maintains a valuation allowance on all of its net deferred tax assets. A valuation allowance is required when, based upon an assessment of various factors, including recent operating loss history, anticipated future earnings, and prudent and reasonable tax planning strategies, it is more likely than not that some portion of the deferred tax assets will not be realized.

 

10.COMMITMENTS AND CONTINGENCIES

Licensing11. COMMITMENTS AND CONTINGENCIES

(a)The Company’s manufactured and marketed product, Sci-B-Vac™, is a recombinant third generation hepatitis B vaccine whose sales and territories are governed by the Ferring License Agreement (“License Agreement”). Under the License Agreement, the Company is committed to pay Ferring royalties equal to 7% of net sales (as defined therein). Royalty payments have been de minimis for the three and six months ended June 30, 2017 and 2016, respectively.

(b)Under an Assignment and Assumption Agreement, the Company is required to pay royalties to SciGen Singapore equal to 5% of net sales of Sci-B-Vac. Royalty payments have been de minimis for the three and six months ended June 30, 2017 and 2016.

 

Legal Proceedings

 

From time to time, the Company may be involved in certain claims and litigation arising out of the ordinary course of business. Management assesses such claims and, if it considers that it is probable that an asset had been impaired or a liability had been incurred and the amount of loss can be reasonably estimated, provisions for loss are made based on management’s assessment of the most likely outcome. TheAs at March 31, 2018 the Company believes that it maintains adequate insurance coverage for any such litigation matters arising in the normal course of business.

 

Operating Leases

 

The Company has entered into various non-cancelable lease agreements for its office, lab and manufacturing facilities. These arrangements expire at various times through 2022. Rent expense for the three months ended June 30,March 31, 2018 and 2017 was $216 and 2016 was $239 and $92, respectively and for the six months ended June 30, 2017 and 2016 was $456 and $187,$217, respectively.

 

The future annual minimum payments under these leases is as follows:

 

Year ending December 31     
     
Remaining 2017 $455 
2018  734 
Remaining 2018 $836 
2019  681   913 
2020  453   527 
2021  453   451 
2022  38 
Thereafter  38   - 
Total $2,814  $2,765 

 

11.REVENUE BY GEOGRAPHIC REGION

On February 28, 2018 VBI DE signed a two-year term extension, which included additional office space, related to the office space in Cambridge, MA committing it to approximately $461 of rent payments which has been included in the above table.

12. SEGMENT INFORMATION

 

  Three months ended June 30  Six months ended June 30 
  2017  2016  2017  2016 
             
Israel $136  $50  $247  $90 
Asia  47   -   61   4 
North America  150   -   150   - 
South America  -   -   2   - 
Europe  11   32   11   36 
Total $344  $82  $471  $130 

The Company’s Chief Executive Officer (“CEO”) has been identified as the chief operating decision maker. The CEO evaluates the performance of the Company and allocates resources based on the information provided by the Company’s internal management system at a consolidated level. The Company has determined that it has only one operating segment.

 

12.PROPERTY AND EQUIPMENT, NET BY GEOGRAPHIC REGION

Revenues from external customers are attributed to geographic areas based on location of the contracting customers:

 

  

June 30, 2017

  December 31, 2016 
       
Property and equipment in Israel $2,114  $1,850 
Property and equipment in North America  140   - 
Total $2,254  $1,850 
  

Three Months Ended

March 31

 
  2018  2017 
       
Israel $106  $111 
Asia  30   14 
South America  -   2 
Europe  42   - 
Total $178  $127 

 

 19

There was no revenue attributed to our country of domicile, Canada, for the three months ended March 31, 2018 and 2017.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

You should read the following discussion of our financial condition and results of operations in conjunction with the condensed consolidated financial statements and the related notes included elsewhere in this Form 10-Q and with our audited consolidated financial statements included in our annual report on Form 10-K for the year ended December 31, 2016,2017, as filed with the U.S. Securities and Exchange Commission (the “SEC”).

 

OverviewExcept for per share amounts or as otherwise specified to be in millions, amounts presented are stated in thousands.

 

VBI- SciVac Merger

On May 6, 2016, the Company completed its acquisition of VBI DE, pursuant to which Seniccav Acquisition Corporation, a Delaware corporation and a wholly owned subsidiary of the Company, merged with and into VBI DE, with VBI DE continuing as the surviving corporation and as a wholly-owned subsidiary of the Company (the “VBI-SciVac Merger”). Upon completion of the VBI-SciVac Merger, the Company changed its name to “VBI Vaccines Inc.” and its common shares commenced trading on The NASDAQ Capital Market. The common shares began trading on The NASDAQ Capital Market under the ticker symbol “VBIV.” Prior to the VBI-SciVac Merger, the Company’s common shares were only listed on the Toronto Stock Exchange (the “TSX”) under the symbol “VAC.” Following the effective time of the VBI-SciVac Merger, the common shares began to trade on the TSX under the new symbol “VBV.”

Principal OperationsOverview

 

We are a commercial stagecommercial-stage, biopharmaceutical company developing next generation vaccines to address unmet needs in infectious disease and immuno-oncology. Our first marketedWe currently manufacture our product, is Sci-B-Vac®, a third-generation hepatitis B virus (“HBV”) vaccine, that mimics all three viral surface antigens of the hepatitis B virus. Sci-B-Vacwhich is approved for use in Israel and 14 other countries. Our wholly-owned subsidiary, SciVac Ltd., manufactures Sci-B-Vac, has not yet been approved by the FDA, EMA or Heath Canada. The Sci-B-Vac vaccine has demonstrated safety and efficacy in Rehovot, Israel.

Weare also advancing our two platform technologies – our “enveloped” virus-like particle (“eVLP”) platform technologynearly 500,000 patients in currently licensed markets. Several clinical trials have shown rapid and our thermostable lipid particle vaccine (“LPV”) technology.

-

Our eVLP platform technology enables the development of enveloped virus-like particle vaccines that closely mimic the target virus to elicit a potent immune response. We are advancing a pipeline of eVLP vaccines, with lead programs in both infectious disease, with our congenital cytomegalovirus (“CMV”) vaccine, and in immuno-oncology, with our therapeutic glioblastoma multiforme (“GBM”) vaccine candidate.

-Our LPV thermostability technology is a proprietary formulation of lipids and process that allows vaccines and biologics to preserve stability, potency, and safety at temperatures outside of the most common cold chain storage requirements of 2oC to 8oC.

Sci-B-Vac Clinical Program

Recently, we completed a post-marketinghigh rates of seroprotection with Sci-B-Vac. The Phase IV clinical study, conducted in Israel for Sci-B-Vacin order to confirmqualify a new in-house reference standard for regulatory and quality control purposes. Sci-B-Vac has not yet been approved by the U.S. Food and Drug Administration (the “FDA”), the European Medicines Agency (the “EMA”) or Health Canada (“HC”). VBI ispurposes, was successfully completed. We are currently developingenrolling patients in a pivotal Phase III clinical program, the results of which are intended to support regulatory and marketing authorization application submissions to obtain FDA, EMA, and HCHealth Canada market approvals for commercial sale of Sci-B-Vac in the United States,U.S., Europe, and Canada respectively. On July 11, 2017, we announced plans for a global Phase III clinical program for Sci-B-Vac following discussions with the FDA, the EMA,Our wholly-owned subsidiary in Rehovot, Israel currently manufactures and HC. The Phase III program is expected to be a global 15-month program, consisting of two concurrent Phase III studies – a safety and immunogenicity study (“PROTECT”) and a lot-to-lot consistency study (“CONSTANT”), enrolling approximately 4,800 subjects. The Phase III program is expected to be conducted at approximately 40 sites across the U.S., Europe, and Canada.

 20

PROTECT – Safety and Immunogenicity Study

PROTECT will be a double-blind, two-arm, randomized, controlled study. Approximately 1,600 adult subjects, age 18 years and older, will be randomized in a 1:1 ratio to receive either a three-dose course of Sci-B-Vac 10μg or a three-dose course of the control vaccine, Engerix-B® 20μg. Enrollment will be stratified by age group.

The co-primary objectives of the study will be:

To demonstrate non-inferiority of the seroprotection rate induced by Sci-B-Vac as compared to Engerix-B four weeks after the third vaccination in adults age 18 and older.
To demonstrate superiority of the seroprotection rate induced by Sci-B-Vac as compared to Engerix-B four weeks after the third vaccination in adults older than 45 years of age.

The study will also include multiple secondary objectives to evaluate the speed to seroprotection and the overall safety and tolerability of Sci-B-Vac as compared to Engerix-B.sells Sci-B-Vac.

 

CONSTANT – Lot-to-Lot Consistency Study

CONSTANT will be a double-blind, four-arm, randomized, controlled study. Approximately 3,200 adult subjects, age 18-45 years, will be randomized in a 1:1:1:1 ratio to receive one of four three-dose courses: Lot A of Sci-B-Vac 10μg, Lot B of Sci-B-Vac 10μg, Lot C of Sci-B-Vac 10μg, or the control vaccine Engerix-B® 20μg.

The primary objectiveWe are also advancing a pipeline of thisenveloped virus-like particle (“eVLP”) vaccines, developed with our eVLP platform technology that allows for the design of enveloped virus-like particles that closely mimic the target viruses. We have lead programs in both infectious disease, with our congenital cytomegalovirus (“CMV”) vaccine candidate, and in immuno-oncology, with our glioblastoma multiforme (“GBM”) vaccine candidate. CMV is an infection that, while common, can lead to serious complications in babies and people with weak immune systems. In September 2016, we completed the enrollment and initial dosing of 128 participants in the Phase I clinical study will be to demonstrate lot-to-lot consistency for immune response as measured by geometric mean concentration (GMC) of antibodies across three independent, consecutive lots of Sci-B-Vac four weeks after the third vaccination.

The secondary objective will be to evaluate safety and efficacy of Sci-B-Vac as compared to Engerix-B.

On June 14, 2017, HC provided us with a No Objection Letter for both Sci-B-Vac Phase III clinical studies, which authorized us to proceed with theSci-B-VacPhase III clinical studies as described in our clinical trial application.

Congenitalits preventative CMV Vaccine Candidate (eVLP)

Our second lead program is a vaccine for congenital CMV a leading cause of birth defects, that is in Phase I development.

candidate. In July 2017, we announced interim data read-outfrom the Phase I clinical study of safety data through day 84 of the study and initial immunogenicity signals in participant samples collected one month after the second of three planned vaccine doses as follows:

Safety:The vaccine was well tolerated at all doses, with no safety signals.
Immunogenicity:

The vaccine induced antibody responses against the CMV glycoprotein B (gB) antigen with clear evidence of dose-dependent boosting after the second vaccination.
Immunization with the highest dose of the vaccine induced seroconversion in 100% of subjects after just two vaccinations.
After two of the three planned vaccinations, neutralizing antibodies against epithelial cell infection were demonstrated in 17% of subjects who received the highest dose of VBI-1501A.
The highest dose of VBI-1501A (2.0μg of gB-G content with alum) has approximately 10-fold less antigen content than that used in several other VLP-based vaccines or in past CMV vaccine candidates.
Formulation of the vaccine with alum enhanced antibody titers.

The finaldoses. Final data read-outread out is anticipated mid-year 2018. In January 2018, VBI initiated dosing of safetyits GBM candidate in a Phase I/IIa clinical program. We expect immunologic data from ongoing biomarker analyses mid-year 2018 and immunogenicity, following a third vaccination isinitial correlations between biomarker analyses and clinical outcomes in the second half of 2018, with 6-month overall survival and progression-free survival expected in the first half of 2018.2019.

 

Therapeutic GBM Vaccines (eVLP)We may also seek to in-license clinical-stage vaccines that we believe complement our product and pipeline portfolio, in addition to technologies that may supplement our therapeutic vaccination efforts in immuno-oncology.

We also have a therapeutic GBM brain cancer vaccine, for which we filed an investigational new drug application on July 12, 2017, which must be reviewed by the FDA before human clinical trials may begin. If successful, we expect to be able to initiate enrollment in a Phase I/IIA clinical study in the second half of 2017.

 21

 

At present, our operations are focused on:

 

 manufacturingin Rehovot, Israel and sale of Sci-B-Vac in territories where it is currently registered;
reporting the Phase IV study results in Israel as described above;
following approval by FDA, EMA and HC, preparing forconducting the Sci-B-Vac Phase III clinical studiesprogram to support various marketing authorizationsauthorization applications in the U.S., Canada and Europe, once additional funding to advance the clinical studies has been secured;Canada;
   
 completing the Phase I clinical study withfor our CMV vaccine candidate;candidate, VBI-1501;
   
 preparing forconducting the planned Phase I/IIAIIa clinical study of our GBM vaccine candidate;candidate, VBI-1901;
manufacturing in Rehovot, Israel and sale of Sci-B-Vac in territories where it is currently registered;
   
 scaling-up Sci-B-Vac manufacturing capabilities to further commercialize this product and other dose forms for whichin additional markets where we may obtain regulatory approval;
   
 continuing the research and development of our product candidates, including the exploration and development of new product candidates;candidates, including a Zika vaccine candidate;
   
 providing contracted services, primarily to customers in the pharmaceutical and biotechnology sectors;
adding operational, financial and management information systems and human resources support, including additional personnel to support our vaccine development and commercialization activities; and
   
 maintaining, expanding and protecting our intellectual property portfolio.

 

VBI’s income generating activities have been the sale of Sci-B-Vac product in markets where it is approved, though those markets have generated a limited number of sales to-date and R&D services generating fees. VBI has incurred significant net losses and negative operating cash flows since inception and expect to continue incurring losses and negative cash flows from operations as we carry out our, planned clinical, regulatory, R&D, sales and manufacturing activities with respect to the advancement of our Sci-B-Vac and new vaccine candidates. As of March 31, 2018, VBI had an accumulated deficit of approximately $156.2 million and stockholders’ equity of approximately $106.5 million. Our ability to maintain our status as an operating company is dependent upon obtaining adequate cash to finance our clinical development, manufacturing, our administrative overhead and our research and development activities. We plan to finance future operations with existing cash reserves. We expect that we will need to secure additional financing to finance our business plans, if required, which may be a combination of proceeds from the issuance of equity securities, the issuance of additional debt, and revenues from potential collaborations, if any. There is no assurance the Company will manage to obtain these sources of financing, if required. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying financial statements have been prepared assuming that we will continue as a going concern. The financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result should we be unable to continue as a going concern.

We have incurred operating losses since inception, have not generated significant product sales revenue and have not achieved profitable operations. We incurred net losses of $12.3 million for the three months ended March 31, 2018 and we expect to continue to incur substantial losses in future periods. We anticipate that our operating expenses will increase substantially as we continue our clinical studies. These include expenses related to:

continuing the Phase III clinical program for Sci-B-Vac and the Phase I/IIa clinical study of our GBM vaccine candidate;
continuing the research and development of our product candidates;
scaling-up manufacturing capabilities, both at Rehovot and through sub-contractors to commercialize products and dose forms for which we may obtain regulatory approval;
maintaining, expanding and protecting our intellectual property portfolio;
hiring additional clinical, manufacturing, and scientific personnel or contractors; and
operational, financial and management information systems and human resources support, including additional personnel, to support our vaccine development.

In addition, we have incurred and will continue to incur significant expenses as a public company, which subjects us to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act and the rules and regulations of the NASDAQ Capital Market and the Canadian securities regulators. Effective as of March 23, 2018, we voluntarily delisted our common shares from the Toronto Stock Exchange.

In 2017, we raised $71.9 million from equity financings to support our Sci-B-Vac, CMV, and GBM vaccine programs, to continue the advancement of our research programs, and for use in other general corporate purposes. Based upon our current cash position and by monitoring our discretionary expenditures as well as the management of our clinical trial commitments and operating costs, we believe these proceeds will be sufficient to fund our activities, including our approved capital expenditure requirements throughout 2018. We expect, however, that additional financing will be needed in the future to further support clinical, regulatory, research and development, sales and manufacturing, and general business operations.

Since inception, VBI and its subsidiaries collectively have raised approximately $196.6 million in total equity and debt financing to support clinical and research development and general business operations.

Research and Development (“R&D&D”) Services

 

Pursuant to an agreement with the Israel Innovations Authority (formerly the Office of the Chief Scientist in Israel, we areof Israel), the Company is required to make services available for the biotechnology industry in Israel. These services include relevant activities for development and manufacturing of therapeutic proteins according to international standards and cGMPGMP quality level suitable for toxicological studies in animals and clinical studies (Phase I & II) in humans. Service activities include analytics/bio analytics methods for development and process development of therapeutic proteins starting with a lead candidate clone through the upstream, purification, formulation and filling processes and manufacturing for Phase I & II clinical studies.trials.

 

These R&D services are primarily marketed to the Israeli research community in academia and Israeli biotechnology companies in the life sciences lacking the infrastructure or experience in the development and production of therapeutic proteins andin the standards and quality required for clinical studiestrials for human use. In 2016 and 2015, we2017 the Company provided services to more than 10 biotechbiotechnology companies including analytical development, upstream development process, protein purification and formulation and filling for Phase I clinical studies.

VBI Cda also provides R&D services pursuant to a research agreement and certain governmental research and development grants.

Financial Overview

 

Overall Performance

 

WeThe Company had net losses of approximately $9,013$12,251 and $6,416$8,638 for the three months ended June 30,March 31, 2018 and 2017, and 2016, respectively and $17,651 and $7,495 for the six months ended June 30, 2017 and 2016, respectively. At June 30, 2017, we hadThe Company has an accumulated deficit of $122,631,$156,226 at March 31, 2018. The Company had $58,094 of cash on hand of $15,642at March 31, 2018 and net working capital of approximately $9,431.$44,339.

 22

 

R&DCost of revenues

Cost of revenues consist primarily of costs incurred for manufacturing the Sci-B-Vac vaccine, which includes cost of materials, consumables, supplies, contractors and manufacturing salaries.

Research and Development Expenses

 

R&D expenses consist primarily of costs incurred for the development of our CMV, GBM, and Sci-B-Vac vaccines, which include:

 

 the cost of acquiring, developing and manufacturing clinical study materials and other consumables and lab supplies used in our pre-clinical studies;
   
 expenses incurred under agreements with contractors or contract manufacturing organizationsContract Manufacturing Organizations to advance the vaccines into and through completion of clinical studies; and
   
 employee-related expenses, including salaries, benefits, travel and stock-based compensation expense.

 

We expense R&D costs when we incur them.

 

General and Administrative Expenses

 

General and administrativeadministration expenses consist principally of salaries and related costs for executive and other administrative personnel and consultants, including stock-based compensation and travel expenses. Other general and administrativeadministration expenses include professional fees for legal, patent protection, consulting and accounting services, travel and conference fees, including board and scientific advisory board meeting costs, rent, maintenance of facilities, depreciation, office supplies and expenses, insurance and other general expenses. General and administrative expenses are expensed when incurred.

 

We expect that our general and administrativeadministration expenses will increase in the future as a result of adding employees and scaling our operations commensurate with advancing clinical candidates and continuing to support a public company infrastructure. These increases will likely include increased costs for insurance, hiring of additional personnel, board committees, outside consultants, investor relations, lawyers and accountants, among other expenses.

 

Interest Income

 

Interest income consists principally of interest income earned on cash balances and on R&D tax refunds.balances.

 

Interest Expense

 

Interest expense is associated with our previously outstanding convertible notes and the credit facility entered into on July 25, 2014 and subsequently amended on December 6, 2016.

 23

Results of Operations

 

Three and Six Months Ended June 30, 2017March 31, 2018 Compared to the Three and Six Months Ended June 30, 2016March 31, 2017

 

All dollar amounts stated below are in thousands, unless otherwise indicated.

 

  Three months ending March 31       
  2018  2017  Change $  Change % 
Revenue $178  $127  $51   40%
                 
Expenses:                
Cost of revenue  1,413   1,275   138   11%
Research and development  6,964   4,654   2,310   50%
General and administration  3,425   3,045   380   12%
Total operating expenses  11,802   8,974   2,828   32%
                 
Net loss from operations  (11,624)  (8,847)  (2,777)  31%
                 
Interest expenses, net  (539)  (704)  165   (23)%
Foreign exchange (loss) gain  (88)  482   (570)  (118)%
Loss before income taxes  (12,251)  (9,069)  (3,182)  35%
                 
Income tax benefit  -   431   (431)  (100)%
                 
NET LOSS $(12,251) $(8,638) $(3,613)  42%

Revenues

Revenue for the three months ended March 31, 2018 was $178, as compared to $127 for the three months ended March 31, 2017.

 

Revenue by Geographic Region

 

  Three months ended
June 30, 2017
  Three months ended
June 30, 2016
  $ Change  % Change 
             
Revenue in Israel $136  $50  $86   172%
Revenue in Asia  47   -   47   100%
Revenue in North America  150   -   150   100%
Revenue in South America  -   -   -   - 
Revenue in Europe  11   32   (21)  (66)%
Total Revenue $344  $82  $262   320%

 Three months ending March 31     
 Six months ended
June 30, 2017
 Six months ended
June 30, 2016
 $ Change % Change  2018 2017 $ Change % Change 
           $  $     
Revenue in Israel $247  $90  $157   174% $106  $111  $(5)  (5)%
Revenue in Asia  61   4   57   1425% 30 14 16 114%
Revenue in North America  150   -   150   100%
Revenue in South America  2   -   2   100% - 2 (2 (100)%
Revenue in Europe  11   36   (25)  (69)%  42  -  42  100%
Total Revenue $471  $130  $341   262% $178 $127  51  40%

 

Revenue earned in Israel, Asia, South America and Europe for the three months ended June 30,March 31, 2018 and 2017 was $136 as compared to $50 for the three months ended June 30, 2016. The revenue earned in Israel increased by $86, or 172%, primarily as a result of completion of a fee for service project during the second quarter of 2017 compared to 2016. In Asia, we completed a contract with one customer in the three and six month periods ended June 30, 2017 compared to negligible sales in 2016 in that region. For the six month period ended June 30, 2017, the revenue earned in Israel increased by 174% due to several new contracts in 2017 while there was a factory shutdown in 2016.

Revenue earned in North America in the second quarter of 2017 was a result of a services agreement that was completed, whereas there were no similar agreements in North America in the comparative period in 2016 that generated revenue.insignificant.

 

Cost of Revenues

 

Cost of revenues for the three months ended June 30, 2017March 31, 2018 was $1,357$1,413 as compared to $703$1,275 for the three months ended June 30, 2016.March 31, 2017. The increase in the cost of revenues of $654,$138, or 93%11%, was a result of a returning to regular vaccine manufacturing production following maintenanceslightly increased revenue as well as increased headcount and upgrades in the prior year and a related increase of production-related headcount compared to previous year. In the prior year we experienced a significant decrease of production activities due to maintenance and upgrades of our manufacturing facility which necessitated a partial shutdown.

 24

Cost of revenues for the six months ended June 30, 2017 was $2,632 as compared to $1,080 for the six months ended June 30, 2016. The increase in the cost of revenues of $1,552, or 144%, was a result of a returning to regular vaccine manufacturing production, as noted above.salary increases.

 

Research and Development

 

R&D expenses for the three months ended June 30, 2017March 31, 2018 were $4,528,$6,964 as compared to $2,123$4,654 for the three months ended June 30, 2016. The increase of $2,405 was mainly a result of a full three months of expenses in 2017 compared to six weeks post acquisition expenses forMarch 31, 2017. During the three months ended June 30, 2016.

March 31, 2018, the significant increase in the cost of R&D expenses for the six months ended June 30, 2017 were $9,182,is as compared to $2,377 for the six months ended June 30, 2016. The increase of $6,805 was mainly a result of a full six monthsthe increased costs related to the ongoing clinical studies of expensesSci-B-Vac, which commenced patient dosing in December 2017 and our GBM vaccine candidate, which commenced patient dosing in January 2018. This is compared to six weeks post acquisition expenses for the sixthree months ended March 31, 2017 where only the CMV clinical study was ongoing, which commenced patient dosing in June 30, 2016.2016 with the last visit in August 2017.

 

General and Administrative

 

General and administrative (“G&A”) expenses for the three months ended June 30, 2017March 31, 2018 were $2,771$3,425 as compared to $3,045 for the three months ended June 30, 2016March 31, 2017. The G&A expense increase of $3,138. The decrease of $367 was a mainly$380, or 12%, is a result of costs recorded as G&A in 2016 as a result of the plant closureincreased headcount and stock-based compensation expenses.

Net Loss from Operations

The net loss from operations for maintenance and upgrades and legal costs associated with the acquisition in 2016, which did not recur in the three months ended June 30,March 31, 2018 were $11,624 as compared to $8,847 for the three months ended March 31, 2017.

The $2,777 increase in the net loss from operations resulted from the increased cost of revenues, R&D expenses, and G&A expenses, for the six months ended June 30, 2017 were $5,816 compared to the six months ended June 30, 2016 of $5,118. The increase of $698 was mainly due to the increase of stock compensation related expenses of $549 for the six months ended June 30, 2017 compared to the same period in the prior year.discussed above.

 

Loss from Operations

Losses from operations were $8,312 and $17,159 for the three and six months ended June 30, 2017, compared to $5,882 and $8,445 for the three and six months ended June 30, 2016. The losses for all periods presented are a result of the items noted above.

Interest expense,Expense, net

 

InterestThe interest expense netdecrease of $165 is $743 and $1,447largely a result of interest income of $202 earned on cash balances for the three and six months ended June 30,March 31 2018 as compared to minimal interest for the three months ended March 31, 2017. This includesInterest paid on the interest on our outstanding long term-debt plus the amortization oflong-term debt and non-cash accretion related to the debt discount. In 2016, these amountsdiscount were minimal ascomparable for the financing was not yet in place.

three months ended March 31, 2018 and March 31, 2017.

 

Foreign exchange gain (loss)Exchange Gain

 

The foreign exchange gainsloss of $42 and $524$88 for the three and six months ended June 30, 2017 and the foreign exchange losses of $531 and $978 for the three and six month periods ended June 30, 2016 are a result of the change in the foreign currencies in which the foreign currency transactions were denominated for each of those periods.

Income tax benefit

The income tax benefit for the six month period ended June 30, 2017 was a result of the reversal of the deferred tax liability in the three months ended March 31, 2017.2018 as compared to a gain of $482 in the comparative period for 2017, is the result of the fluctuation in the foreign currency exchange rate of the CAD and the NIS as compared to the U.S. dollar.

 

Net lossLoss

 

Losses of $9,013 and $17,651The net loss increased by $3,613, or 42%, from $8,638 for the three and six months ended June 30,March 31, 2017 compared to $6,416 and $7,495$12,251 for the three and six months ended June 30, 2016 are a result ofMarch 31, 2018. The increase in our net loss is mainly attributable to the itemsincrease in our loss from operations as discussed above.

 25

 

Liquidity and Capital Resources

 

 June 30, 2017 

December 31, 2016

 $ Change % Change  March 31, 2018  December 31, 2017  $ Change  % Change 
                  
Cash $15,642  $32,282  $(16,640)  (52)% $58,094  $67,694  $(9,600)  (14)%
Current Assets  18,844   34,358   (15,514)  (45)%  60,352   70,426   (10,074)  (14)%
Current Liabilities  9,413   7,614   1,799   24%  16,013   13,236   2,777   21%
Working Capital  9,431   26,744   (17,313)  (65)%  44,339   57,190   (12,851)  (22)%
Accumulated Deficit  (122,631)  (104,980)  (17,651)  (17)% $(156,226) $(143,975)  (12,251)  9%

 

As at June 30, 2017,March 31, 2018, we had cash of $15,642$58,094 as compared to $32,282$67,694 as at December 31, 2016.2017. As at June 30, 2017, weMarch 31, 2018, the Company had working capital of $9,431$44,339 as compared to working capital of $26,744$57,190 at December 31, 2016.2017. Working capital is calculated by subtracting current liabilities from current assets.

 

On June 20, 2016,We expect that we closed an equity private placement, pursuantwill need to which we sold an aggregate of 3,269,688 common shares at a price of approximately $4.16 per share for total gross proceeds of approximately $13.6 million.

On December 6, 2016, we raised $10.6 millionsecure additional financing in an equity financing transaction with Perceptive Life Sciences Master Fund Ltd. and Titan-Perc Ltd., pursuantthe future to which we sold an aggregate of 3,475,000 common shares at a price of $3.05 per share, for total gross proceeds of approximately $10.6 million. In a concurrent debt financing transaction with Perceptive Credit Holdings, LP (“Perceptive Credit”), we raised an additional $12.8 million, net of $360 in deferring financing charges. Additionally, Perceptive Credit increased its current credit agreement with us by funding an additional $13.2 million in secured debt. In conjunction with the additional debt funding, we issued a 5-year warrant to Perceptive Credit for the purchase of an aggregate of 1,705,053 common shares. Up to 363,771 common shares underlying the warrant may be exercised at a price of $4.13 per share and up to 1,341,282 common shares underlying the warrant may be exercised at a price of $3.355 per share.

Liquidity Outlook

VBI’s income generating activities to-date have been from sales of its Sci-B-Vac product in markets that have generated a limited number of sales to-date, as well as fees fromfurther support clinical, regulatory, research and development, (“R&D”) services. VBI has incurred significant net lossessales and negative operatingmanufacturing and general business operations. We base this belief on assumptions that are subject to change, and we may be required to use our available cash flows since inception. Asresources sooner than we currently expect. The Company expects a need to raise additional funds in order to continue its ongoing development programs. The additional funds may be in the form of June 30, 2017, VBI had an accumulated deficit of approximately $122,631. Our ability to maintain our status as an operating company is dependent upon obtaining adequate cash to finance our clinical development, our administrative overhead and our research and development activities. We plan to finance future operations withadditional debt, equity or a combination of existing cash reserves, proceeds fromboth and may require that additional warrants be issued. To date, the issuance of equity securities, the issuance of additional debt,Company has been able to obtain financing as and revenues from potential collaborations, if any. Therewhen it was needed; however, there is no assurance that financing will be available in the Companyfuture, or if it is, that it will manage to obtain these sourcesbe available at acceptable terms.

The report of financingour independent registered public accounting firm on reasonable terms or at all. These factors raise substantial doubt aboutour consolidated financial statements for the year ended December 31, 2017 contains an explanatory paragraph regarding our ability to continue as a going concern. The accompanying financial statements have been prepared assuming that wethe Company will continue as a going concern.concern; however, the above conditions raise substantial doubt about the Company’s ability to do so. The financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result should wethe Company be unable to continue as a going concern. The Company’s long-term success and ability to continue as a going concern is dependent upon obtaining sufficient capital to fund the research and development of its products, to bring about their successful commercial release, to generate revenue and, ultimately, to attain profitable operations or, alternatively, to advance its products and technology to such a point that they would be attractive candidates for acquisition by others in the industry.

 

On October 30, 2017, we closed an underwritten public offering and a concurrent registered direct offering of an aggregate of 23,575,410 common shares at a price of $3.05 per share for total gross proceeds of $71,905. In addition, in connection with the registered direct offering, the Company issued four-year warrants to purchase 550,000 common shares at an exercise price of $3.34 per share. The Company incurred $4,683 of cash issuance costs related to the offering resulting in net cash proceeds of $67,222. We have incurred operating losses since inception, have not generated significant product sales revenue and have not achieved profitable operations. We incurred a net losswill continue to use the proceeds of $9,013the underwritten public offering to support our Sci-B-Vac, CMV, and $17,651 for the three and six months ended June 30, 2017 and we expectGBM vaccine program, to continue to incur substantial losses in future periods. We anticipate that our operating expenses will increase substantially as we continue the clinical developmentadvancement of our Sci-B-Vac productresearch programs and CMV vaccine candidates, as well as advance our pre-clinical-stage product candidate, GBM. These include expenses related to:

 26

completing the CMV Phase I clinical study, a planned GBM Phase I/IIA clinical study and preparation to start a Sci-B-Vac Phase III program;

continuing the research and development of our product candidates;
scaling-up manufacturing capabilities through sub-contractors to commercialize products and dose forms for which we may obtain regulatory approval;
maintaining, expanding and protecting our intellectual property portfolio;
hiring additional clinical, manufacturing, and scientific personnel or contractors; and
adding operational, financial and management information systems and human resources support, including additional personnel, to support our vaccine development and commercialization activities.

for other general corporate purposes.

Our actual future capital requirements will depend on many factors, including the progress and results of our clinical studies,trials, the duration and cost of discovery and preclinical development, laboratory testing and clinical studiestrials for our products, the timing and outcome of regulatory review of our products, product sales outside of Israel, the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims and other intellectual property rights, the number and development requirements of other product candidates that we pursue and the costs of commercialization activities, including product marketing, sales and distribution.

 

As stated above, weThe Company will require significant additional funds to conduct clinical and non-clinical studies,trials, achieve regulatory approvals, and, subject to such approvals, commercially launch its products.

We expect to finance our products.future cash needs through public or private equity offerings, debt financings, or corporate collaboration and licensing arrangements. Although we are pursuing different opportunities, other than as disclosed in this report, we currently do not have any signed commitments for future external funding. We may need to raise additional funds more quickly if one or more of our assumptions prove to be incorrect or if we choose to expand our product development efforts more rapidly than we presently anticipate. We may also decide to raise additional funds even before we need them if the conditions for raising capital are favorable. Additional equity or debt financing, grants or corporate collaboration and licensing arrangements may not be available on acceptable terms, if at all. If adequate funds are not available, we may be required to delay, reduce the scope of or eliminate our R&D programs, reduce our planned commercialization efforts or obtain funds through arrangements with collaborators or others that may require us to relinquish rights to certain product candidates that we might otherwise seek to develop or commercialize independently.

To the extent we raise additional capital by issuing equity securities or obtaining borrowings convertible into equity, ownership dilution to existing stockholders will result and future investors may be granted rights superior to those of existing stockholders. The incurrence of indebtedness or debt financing would result in increased fixed obligations and could also result in covenants that would restrict our operations. Our ability to obtain additional capital may depend on prevailing economic conditions and financial, business and other factors beyond our control. The unstable economic environment in Europe, and disruptions in the U.S. and global financial markets may adversely impact the availability and cost of credit, as well as our ability to raise money in the capital markets. Current economic conditions have been, and continue to be volatile. Continued instability in these market conditions may limit our ability to access the capital necessary to fund and grow our business.

 

Net cash used inby Operating Activities

 

WeThe Company incurred net losses of $17,651$12,251 and $7,495$8,638 in the sixthree months ended June 30,March 31, 2018 and 2017, respectively. The Company used $8,578 and 2016, respectively. We used $16,132 and $6,887$8,244 in cash for operating activities during the sixthree months ended June 30,March 31, 2018 and 2017, and 2016, respectively. The increase in cash outflows is largely as a result of increased professional fees and additional operating costsnet losses related to the increased R&D expenses related to the advancement of the CMVoffset by an increase in net changes in working capital items, specifically accounts payable and Sci-B-Vac vaccines. 

other current liabilities.

Net cash used in and provided by Investing Activities

 

Cash flows used in investing activities decreasedincreased by $2,289$749, from $1,867 cash provided by investing activities$266 for the sixthree months ended June 30, 2016March 31, 2017 to $422 of cash used in investing activities$1,015 for the sixthree months ended June 30, 2017March 31, 2018. The increase was largely related to the purchase of additional property and equipment in SciVac in 2017. Going forward,SciVac. As part of scaling up of our manufacturing capabilities, we willwere, and are continued to be, required to refresh somepurchase additional manufacturing equipment and information technology equipment and to purchase additional R&D equipment.

 

Net cash used in and provided byreceived from Financing Activities

 

Cash flows related to financing activities were not significant in sixthree months ended June 30, 2017. ForMarch 31, 2017 and 2018.

The Company’s long-term success and ability to continue as a going concern is dependent upon obtaining sufficient capital to fund the six month period ended June 30, 2016,research and development of its products, to bring about their successful commercial release, to generate revenue and, ultimately, to attain profitable operations or, alternatively, to advance its products and technology to such a point that they would be attractive candidates for acquisition by others in the cash received fromindustry.

To date, the Company has been able to obtain financing activities reflectsas and when it was needed; however, there is no assurance that financing will be available in the financing obtained.future, or if it is, that it will be available at acceptable terms.

 

Off-Balance Sheet Arrangements

 

As of June 30, 2017 we hadMarch 31, 2018, the Company has no off-balance sheet arrangements.transactions, arrangements, obligations (including contingent obligations), or other relationships with unconsolidated entities or other persons that have, or may have, a material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.

 

Commitment and Contingencies

LeasesTabular Disclosure of Contractual Obligations

 

The remaining minimum annual lease commitments relating to office, labtabular disclosure of contractual obligations is disclosed in the 2017 10-K and manufacturing facilitiesthere have been no material changes during the next five years are as follows. Seethree months ended March 31, 2018, other than disclosed in Note 10, Commitments and Contingencies11 of the Notes to the condensed consolidated financial statements for further discussion.Condensed Consolidated Financial Statements.

 27

The future annual minimum payments under these leases is as follows:

Year ending December 31   
    
Remaining 2017 $455 
2018  734 
2019  681 
2020  453 
2021  453 
Thereafter  38 
Total $2,814 

 

Critical Accounting Policies and Estimates

 

There have been no changes to our critical accounting policies during the three months ended June 30, 2017.March 31, 2018. Critical accounting policies and the significant accounting estimates made in accordance with such policies are regularly discussed with the Audit Committee of the Company’s board of directors. Those policies are discussed under “Critical Accounting Policies” in our “Management’s Discussion and Analysis of the Financial Condition and Results of Operations” included in Item 7, as well as in our condensed consolidated financial statements and the footnotes thereto, included in our 2016 annual report on the Form 10-K filed with the Securities and Exchange Commission on March 20, 2017.2017 10-K.

 

Trends, Events and Uncertainties

 

As with other companies that are in the process of commercializing novel vaccines, we will need to successfully manage normal business and scientific risks. R&DResearch and development of new technologies is, by its nature, unpredictable. We cannot assure you that our technology will be adopted, that we will ever earn revenues sufficient to support our operations, or that we will ever be profitable. Furthermore, other than as discussed in this Form 10-Q,report, we have no committed source of financing and may not be able to raise money as and when we need it to continue our operations. If we cannot raise funds as and when we need them, we may be required to severely curtail, or even to cease, our operations.

Other than as discussed above and elsewhere in this Form 10-Q, we are not aware of any trends, events or uncertainties that are likely to have a material effect on our financial condition.

 

Recent Accounting Pronouncements

 

See Note 3 New Accounting Pronouncements, of Notes to the Condensed Consolidated Financial Statements.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

Not applicable.The quantitative and qualitative disclosures about market risk are disclosed in the 2017 10-K and there have been no material changes during the three months ended March 31, 2018.

 

Item 4. Controls and Procedures

 

Disclosure Controls and Procedures

 

Our management has evaluated, under the supervision and with the participation of our Chief Executive Officer (our principal executive officer) and our Chief Financial OfficerSenior Vice-President, Finance (our principal financial officer), the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Form 10-Q as defined in Rule 13a-15(e) or Rule 15d-15(e) under the Exchange Act as of the end of the period covered by this Form 10-Q.Act. Based on that evaluation, our Chief Executive Officer and our Chief Financial OfficerSenior Vice-President, Finance have concluded that, as of the end of the period covered by this Form 10-Q, our disclosure controls and procedures are effective in ensuring that information required to be disclosed in our Exchange Act reports is (1) recorded, processed, summarized and reported in a timely manner, and (2) accumulated and communicated to our management, including our Chief Executive Officer and our Chief Financial Officer,Senior Vice-President, Finance, as appropriate, to allow timely decisions regarding required disclosure.

 

Changes in Internal Control Over Financial Reporting

 

There has beenDuring the three months ended March 31, 2018, we began implementation of a new enterprise resource planning (“ERP”) system to support our procurement and financial reporting processes. We implemented this new ERP system to enhance our overall system of internal control over financial reporting through further automation and integration of business processes. The ERP system was not implemented in response to any identified deficiency or material weakness in our internal control over financial reporting. As a result of this implementation, we have modified the design and documentation of certain internal control processes and procedures relating to the ERP system. We will continue to implement modules of the ERP system through 2018 relating mainly to inventory, manufacturing and quality processes.

Other than the ERP system implementation described above, there were no significant changes in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during our lastthe fiscal quarter ended June 30, 2017March 31 2018 that hashave materially affected, or isare reasonably likely to materially affect, our internal control over financial reporting.

 

27 28
 

 

PART II—OTHER INFORMATION

 

Item 1. Legal Proceedings

 

From time to time, wethe Company may be involved in certain claims and litigation arising out of the ordinary course and conduct of business. Management assesses such claims and, if it considers that it is probable that an asset had been impaired or a liability had been incurred and the amount of loss can be reasonably estimated, provisions for loss are made based on management’s assessment of the most likely outcome.

 

Item 1A. Risk Factors

 

A description of the risks associated with our business, financial condition and results of operations is set forth in “Item 1A. Risk Factors” of our annual report on Form 10-K for the fiscal year ended December 31, 2016,2017, as filed with the SEC on March20, 2017, whichFebruary 26, 2018. There have not materially changed, except forbeen no material changes to these risks during the following:three months ended March 31, 2018.

Our business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in our cyber-security.

In the ordinary course of our business, we collect and store sensitive data, including intellectual property, research data, our proprietary business information and that of our suppliers, technical information about our products, clinical trial plans and employee records. Similarly, our third-party providers possess certain of our sensitive data and confidential information. The secure maintenance of this information is critical to our operations and business strategy. Despite the implementation of security measures, our internal computer systems, and those of third parties on which we rely, are vulnerable to damage from computer viruses, malware, ransomware, cyber fraud, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or cyber-intrusions over the Internet, attachments to emails, persons inside our organization, or persons with access to systems inside our organization. The risk of a security breach or disruption, particularly through cyber-attacks or cyber intrusion, including by computer hackers, foreign governments, and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased. Any such breach could compromise our networks and the information stored there could be accessed, publicly disclosed, encrypted, lost or stolen. Any such access, inappropriate disclosure of confidential or proprietary information or other loss of information, including our data being breached at third-party providers, could result in legal claims or proceedings, liability or financial loss under laws that protect the privacy of personal information, disruption of our operations or our product development programs and damage to our reputation, which could adversely affect our business. For example, the loss of clinical trial data from completed or ongoing or planned clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

a) Sales of Unregistered Securities

 

There have been no unregistered sales of securities during the period covered by this Form 10-Q that have not been previously reported in a current report on Form 8-K. The Company has not made any purchases of its own securities during the time period covered by this Form 10-Q.

c) Issuer Purchases of Equity Securities

 

None.

 

Item 3. Defaults Upon Senior Securities

 

Not applicable.None.

 

Item 4. Mine Safety Disclosure

 

Not applicable.

 

Item 5. Other Information

 

None.The information set forth below is included herein for the purpose of providing the disclosure required under “Item 1.01 - Entry into a Material Definitive Agreement” of Form 8-K  .

 

Item 6. Exhibits

 

See the Exhibit Index following the signature page to this Form 10-Q for a list of exhibits filed or furnished with this Form 10-Q, which Exhibit Index is incorporated herein by reference.

 

 29

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

Date: July 31, 2017VBI VACCINES INC.
By:/s/ Jeff Baxter

Jeff Baxter

President & Chief Executive Officer

(Principal Executive Officer)

By:/s/ Egidio Nascimento
Egidio Nascimento

Chief Financial Officer

(Principal Financial Officer)

 30

EXHIBIT INDEX

 

Exhibit
No.
 Description
   
3.1 Articles (incorporated by reference to Exhibit 3.1 to the registration statement on Form F-4 (SEC File No. 333-208761), filed with the SEC on December 23, 2015).
   
3.2 Notice of Articles (incorporated by reference to Exhibit 3.2 to Amendment No. 1 to the registration statement on Form F-4 (SEC File No. 333-208761), filed with the SEC on February 5, 2016).
   
3.3 Form of Notice of Alteration (incorporated by reference to Exhibit 3.3 to Amendment No. 1 to the registration statement on Form F-4 (SEC File No. 333-208761), filed with the SEC on February 5, 2016).
   

10.1

10.1+
 

Amendment to Consulting Agreement with F. Diaz-Mitoma Professional Corporation, dated February 19, 2018 (incorporated by reference to Exhibit 10.57 to the annual report on Form 10-K (SEC File No. 001-37769), filed with the SEC on February 26, 2018).

10.2Amendment to Sublease Lease, dated January 21, 2018, by and between Green Power YE and SciVac Ltd. (incorporated by reference to Exhibit 10.58 to the annual report on Form 10-K (SEC File No. 001-37769), filed with the SEC on February 26, 2018).
10.3Waiver Agreement, dated as of May 12, 2017,February 21, 2018, by and between VBI Vaccinesamong Variation Biotechnologies (US), Inc., the Guarantors party thereto, and Perceptive Credit Holdings, LP (incorporated by reference to Exhibit 10.110.59 to Quarterly Reportthe current report on Form 10-Q,8-K (SEC File No. 001-37769), filed with the SEC on May 15, 2017).February 26, 2018.
10.4*Amendment to lease agreement among American Twine Limited Partnership and Variation Biotechnologies (US), Inc. 
   
31.1* Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934.
   
31.2* Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934.
   
32.1** Certification of Chief Executive Officer pursuant to Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350.
   
32.2** Certification of Chief Financial Officer pursuant to Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350.

101.INS* XBRL Instance Document.
   
101.SCH* XBRL Taxonomy Extension Schema Document.
   
101.CAL* XBRL Taxonomy Extension Calculation Linkbase Document.
   
101.DEF* XBRL Taxonomy Extension Definition Linkbase Document.
   
101.LAB* XBRL Taxonomy Extension Labels Linkbase Document.
   
101.PRE* XBRL Taxonomy Extension Presentation Linkbase Document.

 

* Filed herewith.

 

** Furnished herewith.

 

+ Indicates a management contract or compensatory plan.

 

29 31
 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

Date: May 1, 2018VBI VACCINES INC.
By:/s/ Jeff Baxter

Jeff Baxter

President & Chief Executive Officer

(Principal Executive Officer)

By:/s/ Athena Kartsaklis
Athena Kartsaklis

Senior Vice-President, Finance

(Principal Financial and Accounting Officer)